Testing a case-mix classification in palliative care
| ISRCTN | ISRCTN90752212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90752212 |
| Secondary identifying numbers | 31205 |
- Submission date
- 28/02/2017
- Registration date
- 02/03/2017
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In England, the hospice movement has provided a model of good palliative (end of life) care for those with advanced progressive (worsening) disease. However, the care offered around the country can differ greatly. Older people or those with non-cancerous conditions, for instance, are less likely to receive palliative care. There are also major geographical variations in NHS provision often resulting in a mismatch between the palliative care needs of a patient/family, the resources provided to meet those needs, and patient health outcomes achieved. Casemix classifications provide the health care sector with a consistent method of classifying types of patients, their treatment and associated costs. The aim of this study is to follow participants being treated at a range of different places in order to develop a casemix classification for palliative care will enable these inequities in provision to be addressed.
Who can participate?
Adults who are receiving specialist palliative care across inpatient (hospice and hospital), community and outpatient settings, and their family carers.
What does the study involve?
Participants and their family carers are followed by the research team for up to 12 months. Patient participants and their family carers provide data on their symptoms and concerns, whether these are addressed, and other important background information. They also provide inofmration about how they previously used services. The study also includes a post-bereavement survey to family carers where appropriate, to identify symptoms and concerns immediately prior to death, and also family support needs after death. Clinicians collect data about the patient participants including background and health information, episode start and end data, case-mix variables (such as phase of illness, functional status and problem severity), alongside information on patient-level resource use in specialist palliative care settings. These data are linked to patient participant data, encrypted and transferred to the central database and analysed to understand how to better match patient-level resource use to needs.
What are the possible benefits and risks of participating?
Participants will benefit from improved matching of resources to needs at an individual level. There are no notable risks involved with participating.
Where is the study run from?
Inpatient, community and outpatient settings throughout England (UK)
When is the study starting and how long is it expected to run for?
February 2016 to September 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Fliss Murtagh
fliss.murtagh@kcl.ac.uk
Contact information
Public
King’s College London
Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation
Faculty of Life Sciences & Medicine
Bessemer Road
London
SE5 9PJ
United Kingdom
 ORCID ID |
0000-0003-1289-3726 |
|---|---|
| Phone | +44 207 848 5583 |
| fliss.murtagh@kcl.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ot available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | C-CHANGE Workstream 4: Testing a case-mix classification in palliative care (cohort study) |
| Study acronym | C-CHANGE |
| Study objectives | The aim of this study is to prospectively validate a case-mix classification (a system to group people into classes that are homogeneous in their resource use) for palliative care (previously developed) over time and across the range of complexity, conditions and settings. |
| Ethics approval(s) | London –Bromley Research Ethics Committee, 05/09/2016, ref: 16/LO/1021 |
| Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Palliative and Supportive Care; UKCRC code/ Disease: Other/ Ill-defined and unknown causes of mortality |
| Intervention | Patient participants will provide data on their symptoms and concerns, whether these are addressed and other key demographics and social variables. They will also provide retrospective data on their use of services. Family carers will complete data about their own circumstances including their basic demographic information, distress measured by distress thermometer, caregiver burden using the Zarit Caregiver Burden Inventory (6-item version) and questionnaires regarding the patient where the patient is too unwell to complete (e.g., SF-12v2 and Pall-CSRI). These data will be collected from patients and (separately) their main family carers using a combination of face-to-face/telephone contacts and postal questionnaires according to participants’ preferences at start, phase change, and end of episodes of care. Where phase exceeds 4 weeks, data items will be captured as for phase change. A sample of 20-25 patients who have experienced at least two transitions of care and family carers will be purposively selected to take part in one or two face-to-face interviews. The interviews will be semi-structured and follow the interview schedule for the patient participants and family carers. Each interviews last 40 minutes, but this will be guided by the participant. In order to provide information on how transitions in care might be better negotiated to improve outcomes and experiences, the interviews will cover these key topics; communication, coordination of care, information and support needs, discharge planning, and experience of transitions. Data from the first five interviews will be analysed and feedback from our Patient and Public Involvement group will be used to refine the interview schedule for subsequent interviews. Participants and their family carers will be followed to test a case-mix classification longitudinally through transitions between settings (e.g. from home to hospital, from hospice to home etc.). The study will also include a post bereavement survey to family carers where appropriate, to identify symptoms and concerns immediately prior to death, and also family support needs after death. Clinicians will collect data about the patient participants on demographic and clinical data, episode start and end data, potential case-mix variables (e.g., phase of illness, functional status and problem severity) alongside information on patient-level resource use in specialist palliative care settings. These data will be linked to patient participant data, encrypted and transferred to the central database and analysed to understand how we can better match patient-level resource use to needs. |
| Intervention type | Other |
| Primary outcome measure | Cost of the episode of care (and cost per phase and per diem) is captured by i) staff activity matrix at every contact, the Palliative care Resource Use Score (PRUS) at change of phase of illness and at the end of episode, and patient/carer completed inventory of palliative care services received based on the Client Services Receipt Inventory (Pall-CSRI) at end of episodes of care or three monthly whichever is earlier over the telephone. |
| Secondary outcome measures | No secondary outcome measures. |
| Overall study start date | 01/02/2016 |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Total final enrolment | 309 |
| Key inclusion criteria | 1. All adult patients (≥18 years) receiving specialist palliative care 2. People with advanced disease, regardless of primary diagnosis 3. Across inpatient (hospice and hospital), community and outpatient settings |
| Key exclusion criteria | 1. Patients considered by clinicians too ill to be approached 2. Not receiving specialist palliative care 3. Aged under 18 years |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 31/05/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Orpington
BR6 8ND
United Kingdom
London
SE26 6DZ
United Kingdom
London
E8 4SA
United Kingdom
Brighton
BN2 5BE
United Kingdom
Brighton
BN2 3EW
United Kingdom
Hove
BN3 7LW
United Kingdom
Poole
BH15 2JB
United Kingdom
Scarborough
YO12 5RE
United Kingdom
Whittington
WS14 9LH
United Kingdom
Sheffield
S11 9NE
United Kingdom
Canterbury
CT2 8JA
United Kingdom
Hornbeam Park Avenue
Harrogate
HG2 8QL
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Sponsor information
University/education
Room 1.8 Hodgkin Building
Guy’s Campus
London
SE1 4UL
England
United Kingdom
| Phone | +44 20 7848 6960 |
|---|---|
| Keith.brennan@kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in a high-impact peer reviewed journal. Dissemination to participating sites through workshops and feedback meetings, and at regional, national and international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Fliss Murtagh (fliss.murtagh@kcl.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/03/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/11/2023 | 09/07/2024 | Yes | No |
Editorial Notes
09/07/2024: Publication reference and total final enrolment added.
12/09/2018: Publication reference added.
03/08/2018: The recruitment end date was changed from 30/04/2018 to 31/05/2018.
26/03/2018: The following changes were made:
1. Recruitment end date was changed from 28/02/2018 to 30/04/2018.
2. Overall trial end date was changed from 31/05/2018 to 30/09/2018.
3. Intention to publish date was changed from 31/12/2018 to 30/09/2019.
4. Pilgrim Hospices, St Michael's Hospice and Harrogate and District NHS Foundation Trust were added as trial participating centres.
